Hi Emily,
out of curiosity I asked the committe manager of TC 210 and kindly got the following information:
"[...] the withdrawal was based on a recommendation to TC 210 plenary, by the CAG (Chair Advisory Group). The recommendation was approved by the attendees at the December 2022 plenary meeting (see RES 329 in ISO/TC 210 N1373). Final approval was issued by the ISO/TMB in June of 2023. FYI, Germany (DIN) was represented by two attendees at the December 2022 meeting.
[he cites additional correspondence that says the following].the content in the ISO 16142 series is outdated and self-limiting to achieve its intended purpose under how it is constructed. The ISO 16142 series utilizes the disbanded Global Harmonization Task Force [GHTF] Essential Principles [EPs]. Additionally, ISO 16142-1/-2 references within, a set of standards that is incomplete and does not address the purpose of mapping standards to such EPs.
[and concludes] In addition, WG 2 of TC 210 plans to introduce a NWIP in near future for a document that aims to replace the withdrawn documents."
Best regards, Christoph
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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 22-Aug-2023 19:43
From: Emily Campbell
Subject: Withdrawal of ISO 16142-1:2016 and ISO 16142-2:2017 - Essential Principles for Medical Devices and Guidance on Selecting Standards
I noticed ISO 16142-1:2016 and ISO 16142-2:2017 were recently moved to withdrawn status on the ISO.org website, but I didn't see an explanation for why. Can it be inferred that they underwent a periodic review process and simply not renewed? Were these replaced by something else?
- ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
- ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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Emily Campbell RAC
Director Regulatory Affairs
Wheeling IL
United States
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